Download International Baclofen Intervention Study (IBIS): The

International Baclofen Intervention Study (IBIS): The safety and efficacy of Baclofen
for alcohol dependence
Chief Investigator Name: Professor Paul
Haber
Start Year: 2006
Total funding: $25,000
Other Investigators: A/Prof Maree Teesson,
Dr Andrew Baillie, Dr Claudia Sannibale, Dr
Kirsten Morley
Priority area: Alcohol interventions
Grant Type: Research Grant
Admin Institution: SSWAHS
Lay description
Alcohol dependence is a widespread and debilitating disorder, but current treatment options have
met with limited success. Preclinical and small clinical studies in the USA and Europe have shown
that Baclofen, a GABA-B receptor agonist, is effective for the treatment of alcohol dependence.
Based on this evidence, a international trial of Baclofen in alcoholic subjects (the IBIS study) from
Italy and Australia was conducted. Baclofen has been used in Australia for many years as a
muscle relaxant for spasticity and enjoys an excellent safety record. The study is a randomised
placebo-controlled trial exploring the efficacy and tolerability of a 12-week regimen of Baclofen
(10mg & 20mg t.i.d.) in conjunction with brief behavioural therapy for reducing heavy drinking in 42
alcohol-dependent individuals.
Research achievements
Analysis of the Australian data (n=39) indicated that patients showed good tolerability to the
Baclofen treatment with no serious adverse events. Moreover, survival analysis revealed a
significantly (p<0.0001) greater chance of remaining free of relapse to heavy drinking (defined a
priori as one or more days of ≥ 4 standard drinks for females and ≥ 5 standard drinks for males) in
individuals allocated to 10mg Baclofen t.i.d compared to placebo or 20mg Baclofen t.i.d. Notably,
however, a drop-out rate of approximately 60% was recorded, with patients anecdotally reporting
that the three times daily dosing regime was difficult to maintain. Nevertheless, these retention
rates are consistent with those reported in the literature for clinical drug and alcohol research
(Thomson et al. 2008). Further study is required to replicate the findings of this study.
Expected future outcomes
Baclofen remains a promising drug in the treatment of alcohol dependence due to its positive
preliminary clinical evidence and established clinical safety profile. In particular, Baclofen is
emerging as a potential treatment for alcohol dependence in those with significant liver disease,
given its minimal liver metabolism (~10-15%) and limited hepatic side-effects. On the basis of
these study results, the study team recently submitted an application for funding to conduct a
large-scale clinical trial of Baclofen in patients with alcoholic liver disease. If awarded, the findings
of that study are likely to have a direct and immediate impact on the management of this common
and life-threatening disorder.
Publications & Key Presentations
These results are being prepared for publication in a relevant peer-reviewed journal.
Name of contact: Dr Stefanie Leung
Email of contact: [email protected]